Rucaparib for Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (CO-338-017)
A Phase 2, Open-Label Study of Rucaparib in Patients with Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Epithelial Ovarian Cancer
Fallopian Tube Cancer
The purpose of this study is to determine which patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib.
Eligibility Criteria (must meet the following to participate in this study)
- Confirmed diagnosis of high-grade epithelial ovarian (serous or endometrioid histology), fallopian tube, or primary peritoneal cancer
- Relapsed/progressive disease as confirmed by CT scan
- Received ≥1 prior platinum-based treatment regimen
- Received platinum-based regimen as last treatment; continuous or switch maintenance treatment as part of this regimen is permitted
- Sensitive to last platinum regimen (disease progression >6 months after the last dose of platinum)
- If <55 years of age at diagnosis, prior history of breast cancer, or close relative (first or second degree) with ovarian cancer or early onset (<age 50) breast cancer, must have been previously tested for gBRCA mutation; after 15 patients harboring the gBRCA mutation are enrolled, no additional patients with a known gBRCA mutation will be allowed to enroll.
- Have biopsiable and measurable disease
Exclusions (conditions that would prevent participation in this study)
- History of prior cancers except for those that have been curatively treated, with no evidence of cancer currently (provided all chemotherapy was completed >6 months prior and/or bone marrow transplant >2 years prior to first dose of rucaparib).
- Prior treatment with any PARP inhibitor
- Symptomatic and/or untreated central nervous system metastases
- Pre-existing duodenal stent and/or any other gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of rucaparib
Other exclusion criteria may apply.
Last UpdatedJuly 07, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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